OECD GLP 3 34 2551

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????????????????????????? ??????????????????????
???????????????????????????????????? OECD GLP
???????? 3 ?????? 3-4 ?????? 2551

• ??.??.??????? ????????????
• 23 ?.?. 2551

2
???????????????

• ??????? ??????????? ????????? ???????????????????
  ??? 9 ??
• ?????????????????????????? ??????????????????????
• ?????? 3 ?????? 2551
• 9.00-12.00 ?. ?????????????????????????? SOP QA
  inspection ??????????????????????????????
• 13.00-17.00 ?. ?????????????????????????? SOP BE
  Report ??????????????????????????????

3
???????????????

• ?????? 4 ?????? 2551
• 9.00-12.00 ?. ?????????????????????????? SOP BE
  Report ??????????????????????????????
• 13.00-15.00 ?. ?????????????????????????? SOP BE
  Report ??????????????????????????????
• 15.30-17.00 ?. ??????????/??????????/?????????????
  ?? SOP QA Inspection ??? SOP BE Report

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??????????????????? OECD GLP ????????? 2550-2551
5
????????????????????????????????????????????????
?????????? 1003.14/? 5397 ???????? 19 ?????? 2548
???????????????????????????????????? ?????????????
???????????????????????????? ?????????????????????
????????????????????? ISO 17025 ??????????? GLP
??????????????????????????????????????????????????
???????? ?????????????????????????? ??????????????
?????????????????????? GCP ??????? ?????????????
? ?????? ???? ?????????
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• ISO International Organization for
  Standardization
• IEC International Electrotechnical Commission

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ISO/IEC 17025 2005

• General requirement for the competence of
• testing and calibration laboratories

Top Management, QM, TM
Internal audit, Management review
Quality management policy, Objective,
Documentation and control, Contract, Supplies,
Customer, Complaints, NC, Correction, Prevention,
Improvement, Control of record Sampling, Sample
handling, Reporting IQC PT Personnel Test
method, Equipment AccommEnvironment
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ISO/IEC 17025
4. ???????????????????????? (Management
Requirements)

• 4.1 ???????
• 4.2 ????????????????
• 4.3 ???????????????
• 4.4 ?????????????????? ????????????????
• ???????????
• 4.5 ???????????????????????
• 4.6 ?????????????????????????
• 4.7 ??????????????????
• 4.8 ????????????

4.9 ???????????????????????
????????????????? 4.10 ??????????? 4.11
?????????????????? 4.12 ???????????????????? 4.1
3 ??????????????? 4.14 ???????????????????????
? 4.15 ????????????????????
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ISO/IEC 17025

• 5. ??????????????????? (Technical Requirements)
• 5.1 ??????
• 5.2 ???????
• 5.3 ??????????????????????
• 5.4 ????????????????????????????????????????????
• 5.5 ??????????
• 5.6 ???????????????????????
• 5.7 ??????????????
• 5.8 ??????????????????????
• 5.9 ?????????????????????????
• 5.10 ???????????????????

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• APLAC Asia Pacific Laboratory Accreditation
  Co-operation
• ILAC -gt International Laboratory Accreditation
  Co-operation

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OECD GLP

• OECD Organization for Economic Co-Operation
  and Development
• GLP Good Laboratory Practice
  ???????????????????????????????????
• ??????????????????????????????????????????????????
  ??????????????????????????????????????????????????
  ??? ????????????????????????? ????????????????????
  ?????????????? ???????????????????????
  ??????????? ?????? ??????? ???????????????????????
  ?

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(No Transcript)
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GLP Organization Chart
M
Report
QA
SD
Co-ordinate
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Good Laboratory Practice GLP

• 1. ?????????????????????????????????? (??? 5.2,
  5.3)
• ? ?????????????????????
• ? ????????????
• ? ?????????????
• 2. ?????????????????????? (??? 5.9?)
• ? ??????????????????????????????????????????????
  ??? (????????????)
• ? ????????????? ????????????????????????????????
  ????
• ? ?????????????????? (ear and eye)

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Good Laboratory Practice GLP

• 3. ???????????????????????? (??? 5.3, 5.6)
• 4. ?????????? ????? ?????????? (??? 5.5, 5.6)
• 5. ??????????????????????? ???????? ????????????
  (??? 5.5)
• 6. ???????????????????????????? (??? 5.6, 5.8)
• ? ?????? ????? ??????????? ???????
  ???????????????
• ? ?????????????????????????????????????
• 7. ???????????????????? (SOPs)

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Good Laboratory Practice GLP

• 8. ??????????????????????
• ? ??????????????
• ? ?????????????????
• 9. ???????????????? (??? 5.10)
• ???????????????????????????
• 10. ???????????????????????????? (??? 4.13)

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Flow of the study based on GLP

• Personnel Performance of the study
  Facility

Study Plan

• Facilities
• Apparatus, Material
• and Reagents
• Test Systems
• Test and Reference
• Items

• Test Facility
• Management
• Study Director
• Study Personnel
• Principle Investigator
• Quality Assurance
• Personnel
• etc.

Conduct of the study
Reporting of the study results
Storage and Retention of Records and Materials
Standard Operating Procedures (SOPs)
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Study Plan

• Study Plan (????????????????)
  ??????????????????????????????????????????????????
  ??????????????????????????????????????????????????

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Study Plan

• ???????????
• ?????????????????????????
• ??????????/????????????
• ??????????????????????????????????????
  (?????????????)
• ??????????????????????????????????????/????????
• ??????????????????????????????????????
• ?????????????????????????????

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Study Plan

• ??????????????????????????????????????????????????
  ?????????????????????????????????
• ???????????????????????? (????????????????????????
  ????????)
• ????????????????????????????????
• ????????????????????????????????????????????????
• ??????????????????????????????
• ????????????

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Study Plan

• ??????????????????????/??????????????????????????
  ??????????????????????????? ??????????????????????
  ????????? ????????????????????????????????????????
  ???????? ?????????????? ??????????????????????????
  ???? ????????????????????? ?????????????????
  ??????????????????????????
• ???????????

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SOPs

• 1. SOPs Check
• 2. Personnel training
• 3. Calibration Check and verify the calibration
  records
• 4. Equipments/ Instrument Log books
• 5. General cleanliness of laboratory, work
  benches and instrument
• 6. Biological waste management
• 7. Washing and cleaning of laboratory glassware/
  vials

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SOPs

• 8. Instrument qualification
• 9. Working standard/ reference standard
• 10. Labeling
• 11. Biological samples storage and handling
• 12. Data back up and maintenance
• 13. Handing of chemical and solvents

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SOPs

• 14. In process/ Retrospective audit checklist
• New product initiation
• Method validation
• Validation raw data
• Study protocol approval
• Subject study sample analysis
• Subject study sample analysis raw data

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Information

• 21 ??.?. 51 Internal audit (9.00 AM)
• Exchange\ BE Center\ ????????????????????\ ISO
  17025\ QM

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Thank you